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Commonly known as Tylenol, acetaminophen assists with relieving pain related to headaches, menstruation, colds, sore throats, toothaches, backaches, muscle aches, osteoarthritis, and vaccinations. While it can’t be used to lessen inflammation, the drug classified as a fever and pain reducer cools the body, inhibits the part of the brain that senses pain, and blocks the formation and release of fatty acid prostaglandin E.

During its 50-plus years available, Tylenol and generic acetaminophen have been marketed as a safer alternative to non-steroidal anti-inflammatory drugs (NSAIDs), like aspirin and ibuprofen. Certain prescription painkillers further include it amongst a lengthier list of ingredients, such as codeine, hydrocodone, and oxycodone.

Side Effects

Greater attention has been paid to its side effects in recent years:

  • Hives
  • Itching
  • Swelling of the throat, tongue, lips, hands, feet, lower legs, and ankles
  • Hoarseness
  • Difficulty swallowing or breathing
  • Childhood asthma
  • Rash
  • Liver damage

In the United States, acetaminophen has been found to be the leading cause of acute liver failure, which may be fatal. Yearly, 100,000 calls placed to poison centers, 60,000 emergency room visits, and hundreds of deaths have been attributed to this painkiller.

Accidental overdose, leading to liver failure, remains a risk and can occur even when an individual takes just above the recommended daily amount. Risks increase sharply when the OTC medication is combined with alcohol or anti-seizure drugs.

In all cases, as acetaminophen gets metabolized in the liver, the compound builds up, and as the organ looks to eliminate it, the cytochrome P-450 system attempts to pass it through but then creates a toxic substance called NAPQI.

Treatment within eight hours of overdose greatly increases chances of survival. If this doesn’t occur, liver damage begins in two to three days. As well, pregnant women who overdose on acetaminophen further put their unborn child at risk, as NAPQI passes through the placenta.

Warnings, Lawsuits & Changes

From 2009 to 2012, Tylenol experienced multiple recalls. This can likely be attributed to the FDA’s updated guidelines in 2009, which included potential liver damage, although bacterial contamination was the cause of other related instances.

Along with this, the FDA has recommended manufacturers like McNeill-PPC, Inc. limit the amount of acetaminophen to 325mg per tablet and requires all labels to warn of side effects; maximum dosage should not exceed 4,000mg over a 24-hour period.

By 2011, the FDA confirmed a direct link between acetaminophen usage and liver damage. During 2013, safety warnings further mentioned acetaminophen usage with Stevens-Johnson Syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis. As of October 2013, Johnson & Johnson added a label about liver damage to Extra Strength Tylenol, and more restrictions are expected to go into effect by January 2014.

With lawsuits targeting the manufacturer, including a multi-district case consolidated into the U.S. District Court for the Eastern District of Pennsylvania, plaintiffs allege Johnson & Johnson failed to warn about liver damage risks.